Yeah, this one is likely to be in my "early mistakes" file. Didn't know Rosenwald then. Anyhow, you asked "How is the PD diagnostic submittal coming along?" BLSI finally answers.
>>BOSTON--(BW HealthWire)--Feb. 25, 2002-- Boston Life Sciences, Inc. (NASDAQ: BLSI - news) announced that it has completed the testing it believes is necessary to document the chemical and biologic equivalence of the commercial supply of the Company's product candidate for the diagnosis of Parkinsonian Syndromes, ALTROPANE(TM), to that used in its clinical trials of the drug. These studies were necessitated by the change of manufacturer and process from clinical trial scale to full cGMP commercial scale. The results of these equivalency studies revealed no detectable differences in chemical or biologic properties between the two sources of material, the Company said.
``Although it took more time than we anticipated to complete the testing, we are pleased with the results, and have incorporated them in the pre-NDA Briefing Document the Company has submitted to the FDA,'' stated Dr. Marc Lanser, Chief Scientific Officer of BLSI. In connection with that submission, Dr. Lanser added that the Company has requested a teleconference with the FDA to discuss, among other things, the scheduling of a pre-NDA meeting. The Company hopes this meeting will be held during the second quarter.<<
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Cheers, Tuck |
